MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD. 2; STAND, INFUSION

Model Number N/A

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of judqf168 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when the catheter was maintained the following day after placement, the latch of the statlock was found broken.It made the catheter unable to be used properly.

• Brand Name: STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD. 2
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10457577
• MDR Text Key: 204535706
• Report Number: 3006260740-2020-03050
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741081507
• UDI-Public: (01)00801741081507
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: CV0220CE
• Device Lot Number: JUDQF168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR